BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 12021069 · Received June 17, 2021

    Report

    Report Number
    3003761017-2021-00117
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    June 9, 2021
    Report Date
    October 25, 2021
    Product Code
    LOZ
    UDI-DI
    00858000003107
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DRIVER'S PATIENT DATA FILE WAS REVIEWED AND REVEALED AN EMERGENCY BATTERY ERROR ALARM THUS CONFIRMING THE CUSTOMER-REPORTED ALARM. DURING INCOMING FUNCTIONAL TESTING THERE WERE NO ABNORMALITIES OBSERVED WITH THE COMPANION 2 DRIVER. THE CUSTOMER-REPORTED INABILITY OF THE DRIVER TO TURN ON WAS NOT ABLE TO BE REPLICATED DURING THE INVESTIGATION. THE EMERGENCY BATTERY WAS SEPARATELY EVALUATED AND NO DIMINISHED OR PERMEANT FAULT ALARMS WERE FOUND THAT WOULD INDICATE A DEVICE MALFUNCTION. THE EMERGENCY BATTERY WAS THEN SUBJECTED TO A TEN-MINUTE BATTERY DISCHARGE TEST AND THE BATTERY WAS ABLE TO POWER THE DRIVER FOR THE FULL TEN MINUTES. THE EMERGENCY BATTERY MOST LIKELY SEVERELY DEPLETED AND WOULD THEREFORE TAKE A LONGER AMOUNT OF TIME TO CHARGE THAN THE CUSTOMER PROVIDED. C2-900005, COMPANION 2 DRIVER OPERATOR MANUAL, SECTION 12.10, DESCRIBES THE PROPER DRIVER STORAGE REQUIREMENTS: ALWAYS STORE COMPANION 2 DRIVERS IN A HOSPITAL CART OR CADDY THAT IS CONNECTED TO EXTERNAL (WALL) POWER. STORING THE DRIVER WITHOUT EXTERNAL (WALL) POWER MAY CAUSE THE EMERGENCY BATTERY TO DEPLETE AND MAY RENDER THE DRIVER UNUSABLE FOR PATIENT SUPPORT. THIS ISSUE WILL BE MONITORED AND TRENDED AS PART OF THE CUSTOMER EXPERIENCE PROCESS. SYNCARDIA HAS COMPLETED ITS INVESTIGATION AND IS CLOSING THIS FILE. (B)(4) FOLLOW-UP REPORT 1.

    Additional Manufacturer Narrative · 1

    THE COMPANION 2 DRIVER WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS WILL BE PROVIDED IN A FOLLOW-UP MDR. (B)(4).

    Description of Event or Problem · 1

    THE COMPANION 2 DRIVER WAS NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE COMPANION 2 DRIVER EXHIBITED AN EMERGENCY BATTERY ERROR ALARM DURING THE SYSTEM CHECK. ADDITIONALLY, AFTER THE DRIVER WAS DOCKED IN A COMPANION DRIVER CADDY FOR A FEW HOURS, THE DRIVER WOULD NOT TURN ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911935 SYNCARDIA COMPANION 2 DRIVER EXTERNAL PNEUMATIC DRIVER LOZ 397002-001 00858000003107

    Patients

    Seq Age Sex Outcome Treatment
    1